Trial Outcomes & Findings for Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients (NCT NCT01370551)
NCT ID: NCT01370551
Last Updated: 2024-10-15
Results Overview
Estrogens were analyzed using a highly sensitive gas chromatography-mass spectrometry (GC/MS) method. The lower limits of quantitation (LLOQ) were 10.00 pg/ml for E3, 1.The coefficient of variation (CV, intra-assay variation) was 2.0 % for E3 (calibration range (CR) 10.00-500.00 pg/). The lower limits of quantitation (LLOQ) were 1.00 pg/ml for E2, and 2.00 pg/ml for E1.The coefficient of variation (CV, intra-assay variation) was 4.2 % for E2 (CR 1.00-150.00 pg/ml), and 3.4 % for E1 (CR 2.00-300.00 pg/ml).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
-0.5, 0.5, 1, 2, 3, 4, 6, 8, 24 hours on days 0 and 28
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
Gynoflor
Gynoflor vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol:1 x 28 days, then 3x per week x 8 weeks
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Gynoflor
n=16 Participants
Gynoflor vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol: 1 x 28 days, then 3x per week x 8 weeks
|
|---|---|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=5 Participants
|
|
Estriol
|
104.5 pg/ml
STANDARD_DEVIATION 40.9 • n=5 Participants
|
|
Follicule Stimulating Hormone (FSH)
|
107.88 mIU/ml
STANDARD_DEVIATION 48.62 • n=5 Participants
|
|
Luteinizing hormone (LH)
|
36.46 mIU/ml
STANDARD_DEVIATION 11.05 • n=5 Participants
|
|
Sex hormone binding globulin (SHBG)
|
73.04 nmol/l
STANDARD_DEVIATION 29.66 • n=5 Participants
|
|
Vaginal maturation index (VMI)
|
31.2 %
STANDARD_DEVIATION 19.4 • n=5 Participants
|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Lactobacillary grade (LBG)
|
3.9 units on a scale
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Bacterial vaginosis (BV) score
|
0.1 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: -0.5, 0.5, 1, 2, 3, 4, 6, 8, 24 hours on days 0 and 28Estrogens were analyzed using a highly sensitive gas chromatography-mass spectrometry (GC/MS) method. The lower limits of quantitation (LLOQ) were 10.00 pg/ml for E3, 1.The coefficient of variation (CV, intra-assay variation) was 2.0 % for E3 (calibration range (CR) 10.00-500.00 pg/). The lower limits of quantitation (LLOQ) were 1.00 pg/ml for E2, and 2.00 pg/ml for E1.The coefficient of variation (CV, intra-assay variation) was 4.2 % for E2 (CR 1.00-150.00 pg/ml), and 3.4 % for E1 (CR 2.00-300.00 pg/ml).
Outcome measures
| Measure |
Gynoflor
n=16 Participants
Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; once daily for 28 days then 3 times per week for 8 weeks;
|
|---|---|
|
Serum Concentrations of Estriol (E3)
-0.5 h (Day 0)
|
0 pg/ml
Interval 0.0 to 0.0
|
|
Serum Concentrations of Estriol (E3)
-0.5 h (Day 28)
|
0.91 pg/ml
Interval 0.0 to 14.5
|
|
Serum Concentrations of Estriol (E3)
0.5 h (Day 0)
|
3.83 pg/ml
Interval 0.0 to 14.1
|
|
Serum Concentrations of Estriol (E3)
0.5 h (Day 28)
|
1.58 pg/ml
Interval 0.0 to 12.9
|
|
Serum Concentrations of Estriol (E3)
1 h (Day 0)
|
11.04 pg/ml
Interval 0.0 to 18.8
|
|
Serum Concentrations of Estriol (E3)
1 h (Day 28)
|
1.55 pg/ml
Interval 0.0 to 14.4
|
|
Serum Concentrations of Estriol (E3)
2 h (Day 0)
|
72.73 pg/ml
Interval 0.0 to 168.0
|
|
Serum Concentrations of Estriol (E3)
2 h (Day 28)
|
1.96 pg/ml
Interval 0.0 to 16.6
|
|
Serum Concentrations of Estriol (E3)
3 h (Day 0)
|
84.35 pg/ml
Interval 0.0 to 160.0
|
|
Serum Concentrations of Estriol (E3)
3 h (Day 28)
|
2.48 pg/ml
Interval 0.0 to 29.2
|
|
Serum Concentrations of Estriol (E3)
4 h (Day 0)
|
28.29 pg/ml
Interval 0.0 to 67.5
|
|
Serum Concentrations of Estriol (E3)
4 h (Day 28)
|
3.12 pg/ml
Interval 0.0 to 37.7
|
|
Serum Concentrations of Estriol (E3)
6 h (Day 0)
|
0.00 pg/ml
Interval 0.0 to 0.0
|
|
Serum Concentrations of Estriol (E3)
6 h (Day 28)
|
7.33 pg/ml
Interval 0.0 to 39.5
|
|
Serum Concentrations of Estriol (E3)
8 h (Day 0)
|
0.00 pg/ml
Interval 0.0 to 0.0
|
|
Serum Concentrations of Estriol (E3)
8 h (Day 28)
|
10.23 pg/ml
Interval 0.0 to 43.7
|
|
Serum Concentrations of Estriol (E3)
24 h (Day 0)
|
0.00 pg/ml
Interval 0.0 to 0.0
|
|
Serum Concentrations of Estriol (E3)
24 h (Day 28)
|
0.00 pg/ml
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Days 0 and 28Cmax is the highest measured concentration
Outcome measures
| Measure |
Gynoflor
n=16 Participants
Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; once daily for 28 days then 3 times per week for 8 weeks;
|
|---|---|
|
Calculation of Pharmacokinetic Parameters Estriol: Cmax
Cmax (Day 0)
|
104.5 pg/ml
Standard Deviation 40.9
|
|
Calculation of Pharmacokinetic Parameters Estriol: Cmax
Cmax (Day 28)
|
15.8 pg/ml
Standard Deviation 13.9
|
PRIMARY outcome
Timeframe: Days 0 and 28Tmax is the peak time at which the Cmax (maximum concentration) was measured
Outcome measures
| Measure |
Gynoflor
n=16 Participants
Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; once daily for 28 days then 3 times per week for 8 weeks;
|
|---|---|
|
Calculation of Pharmacokinetic Parameters Estriol: Tmax
Tmax (Day 0)
|
2.5 hours
Standard Deviation 0.5
|
|
Calculation of Pharmacokinetic Parameters Estriol: Tmax
Tmax (Day 28)
|
7.2 hours
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: Days 0 and 28Population: PP
Area under the curve from administration to the last measured concentration (AUC0-24)
Outcome measures
| Measure |
Gynoflor
n=16 Participants
Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; once daily for 28 days then 3 times per week for 8 weeks;
|
|---|---|
|
Calculation of Pharmacokinetic Parameters Estriol: Area Under the Curve (AUC)
AUC (0-24h) (Day 0)
|
212 hours * pg/ml
Standard Deviation 93.2
|
|
Calculation of Pharmacokinetic Parameters Estriol: Area Under the Curve (AUC)
AUC (0-24h) (Day 28)
|
130.7 hours * pg/ml
Standard Deviation 147.2
|
SECONDARY outcome
Timeframe: Days 0, 14, 28, 56 and 84Population: PP
Outcome measures
| Measure |
Gynoflor
n=16 Participants
Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; once daily for 28 days then 3 times per week for 8 weeks;
|
|---|---|
|
Baseline / Trough Serum Concentrations of Estriol
Estriol (Day 14)
|
5.11 pg/ml
Standard Deviation 14.01
|
|
Baseline / Trough Serum Concentrations of Estriol
Estriol (Day 28)
|
0.91 pg/ml
Standard Deviation 3.63
|
|
Baseline / Trough Serum Concentrations of Estriol
Estriol (Day 56)
|
0.00 pg/ml
Standard Deviation 0.00
|
|
Baseline / Trough Serum Concentrations of Estriol
Estriol (Day 84)
|
0.00 pg/ml
Standard Deviation 0.00
|
|
Baseline / Trough Serum Concentrations of Estriol
Estriol (Day 0)
|
0.00 pg/ml
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: at all visits during 12 weeksThe normal vaginal pH is 3.8-5.0 pH is a logarithmic scale used to specify the acidity or basicity of aqueous solutions. The scale has values ranging from zero (the most acidic) to 14 (the most basic). Pure water has a pH value of 7. This value is considered neutral-neither acidic or basic.
Outcome measures
| Measure |
Gynoflor
n=16 Participants
Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; once daily for 28 days then 3 times per week for 8 weeks;
|
|---|---|
|
Vaginal pH
Entry (Day 0)
|
6.0 pH
Standard Deviation 0.3
|
|
Vaginal pH
C1 (Day 14)
|
4.6 pH
Standard Deviation 0.5
|
|
Vaginal pH
C2 (Day 28)
|
4.4 pH
Standard Deviation 0.4
|
|
Vaginal pH
C3 (Day 56)
|
4.6 pH
Standard Deviation 0.5
|
|
Vaginal pH
C4 (Day 84)
|
4.5 pH
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Days 0, 14, 28, 56 and 84Population: PP
Outcome measures
| Measure |
Gynoflor
n=16 Participants
Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; once daily for 28 days then 3 times per week for 8 weeks;
|
|---|---|
|
Baseline / Trough Serum Concentrations of Luteinizing Hormone (LH)
LH (Day 0)
|
36.46 mIU/ml
Standard Deviation 11.05
|
|
Baseline / Trough Serum Concentrations of Luteinizing Hormone (LH)
LH (Day 14)
|
34.52 mIU/ml
Standard Deviation 12.18
|
|
Baseline / Trough Serum Concentrations of Luteinizing Hormone (LH)
LH (Day 28)
|
34.02 mIU/ml
Standard Deviation 12.68
|
|
Baseline / Trough Serum Concentrations of Luteinizing Hormone (LH)
LH (Day 56)
|
34.2 mIU/ml
Standard Deviation 49.87
|
|
Baseline / Trough Serum Concentrations of Luteinizing Hormone (LH)
LH (Day 84)
|
35.13 mIU/ml
Standard Deviation 10.34
|
SECONDARY outcome
Timeframe: Days 0, 14, 28, 56 and 84Population: PP
Outcome measures
| Measure |
Gynoflor
n=16 Participants
Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; once daily for 28 days then 3 times per week for 8 weeks;
|
|---|---|
|
Baseline / Trough Serum Concentrations of Sex Hormone Binding Globulin (SHBG)
SHBG (Day 0)
|
73.04 nmol/ml
Standard Deviation 29.66
|
|
Baseline / Trough Serum Concentrations of Sex Hormone Binding Globulin (SHBG)
SHBG (Day 14)
|
74.24 nmol/ml
Standard Deviation 35.35
|
|
Baseline / Trough Serum Concentrations of Sex Hormone Binding Globulin (SHBG)
SHBG (Day 28)
|
71.29 nmol/ml
Standard Deviation 31.88
|
|
Baseline / Trough Serum Concentrations of Sex Hormone Binding Globulin (SHBG)
SHBG (Day 56)
|
73.35 nmol/ml
Standard Deviation 32.76
|
|
Baseline / Trough Serum Concentrations of Sex Hormone Binding Globulin (SHBG)
SHBG (Day 84)
|
72.43 nmol/ml
Standard Deviation 34.57
|
SECONDARY outcome
Timeframe: Days 0, 14, 28, 56 and 84Population: PP
Outcome measures
| Measure |
Gynoflor
n=16 Participants
Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; once daily for 28 days then 3 times per week for 8 weeks;
|
|---|---|
|
Baseline / Trough Serum Concentrations of Follicule Stimulating Hormone (FSH)
FSH (Day 0)
|
107.88 mIU/ml
Standard Deviation 48.62
|
|
Baseline / Trough Serum Concentrations of Follicule Stimulating Hormone (FSH)
FSH (Day 14)
|
103.71 mIU/ml
Standard Deviation 39.76
|
|
Baseline / Trough Serum Concentrations of Follicule Stimulating Hormone (FSH)
FSH (Day 28)
|
98.94 mIU/ml
Standard Deviation 34.95
|
|
Baseline / Trough Serum Concentrations of Follicule Stimulating Hormone (FSH)
FSH (Day 56)
|
103.55 mIU/ml
Standard Deviation 37.53
|
|
Baseline / Trough Serum Concentrations of Follicule Stimulating Hormone (FSH)
FSH (Day 84)
|
105.93 mIU/ml
Standard Deviation 43.69
|
Adverse Events
Gynoflor
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gynoflor
n=16 participants at risk
Gynoflor vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol:1 x 28 days, then 3x per week x 8 weeks
|
|---|---|
|
Reproductive system and breast disorders
Vaginal discharge
|
31.2%
5/16 • Number of events 7 • 12 weeks
|
|
Renal and urinary disorders
cystitis
|
18.8%
3/16 • Number of events 3 • 12 weeks
|
|
Gastrointestinal disorders
Gastro-intestinal disorders
|
18.8%
3/16 • Number of events 5 • 12 weeks
|
|
General disorders
Influenza-like ilness
|
12.5%
2/16 • Number of events 2 • 12 weeks
|
|
Ear and labyrinth disorders
Ear and Labyrinth disorders
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place